Metformin and Beyond: Individualizing Care for Low Back Pain
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change From Baseline in Numeric Pain Rating Scale
研究概览
简要总结
The purpose of the current study is to determine the effects of metformin in non-diabetic patients with low back pain, and identify novel targets for future treatments
详细描述
Outcome measures were updated after the initial submission to clinicaltrials.gov. The outcomes were changed in the Institutional Review Board protocol but not updated on clinicaltrials.gov. These outcome measures have since been updated to reflect what was collected for the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and above
- •Diagnosed with axial low back pain (low back pain more severe than pain in other parts of the body, without radiation of pain into the lower extremities).
- •Women of child bearing potential must have a negative serum pregnancy test at baseline.
排除标准
- •Diagnosed with rheumatoid arthritis, lupus, other autoimmune/systemic inflammatory arthropathies
- •Progressive lower extremity weakness or numbness
- •Recent oral steroid use (within last 3 months)
- •NSAID use
- •Chronic kidney disease (eGFR <60)
- •Diagnosis of diabetes mellitus
- •Subjects must not be pregnant or breastfeeding, or planning to become pregnant or breastfeed during the course of the trial
- •Unable to take an oral medication in a non crushable pill form
- •Taking metformin presently or within the last 6 months
- •History of allergy to metformin
- •History of lactic acidosis
- •Severe Hepatic dysfunction
- •Currently taking a diabetic medication such as sitagliptin, saxagliptin, linagliptin, alogliptin, sitagliptin with metformin
- •Currently taking a Carbonic anhydrase inhibitor such as topiramate, zonisamide, acetazolamide, dichlorphenamide, methazolamide
- •Currently taking cimetidine
研究组 & 干预措施
High Dose Metformin
High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.
干预措施: Metformin (Drug)
Low Dose Metformin
Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.
干预措施: Metformin (Drug)
Placebo
Placebo Group (n=100). Subjects will receive placebo and will be instructed to take either 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months OR take 1 placebo tab for 6 months.
干预措施: Placebo (Drug)
Wait-List Control
Control Group (n=100). Subjects will be told that they are in the wait-list control group. They will have a 3 month "waiting period" before they will be randomized again to a treatment group. They will be randomized to one of the previous groups.
干预措施: Metformin (Drug)
Wait-List Control
Control Group (n=100). Subjects will be told that they are in the wait-list control group. They will have a 3 month "waiting period" before they will be randomized again to a treatment group. They will be randomized to one of the previous groups.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Numeric Pain Rating Scale
时间窗: Up to 15 months
Scores range from 0 to 10 with a higher score indicating more severe pain
Change From Baseline in Oswestry Disability Index (ODI)
时间窗: Up to 15 months
Scores range from 0% to 100% with higher scores indicating greater disability
次要结局
- Change From Baseline in BACPAC (Back Pain Consortium) Minimum Dataset: Pain Outcomes Assessment(Up to 15 months)
- Change From Baseline in 10 Meter Walk Test(Up to 15 months)
- Change From Baseline in Fear Avoidance Questionnaire(Up to 15 months)
- Change From Baseline in STarT Back Tool(Up to 15 months)
- Change From Baseline in 6-item Pain Catastrophizing Scale(Up to 15 months)
- Change From Baseline in Positive Outlook v1.0 - Short Form 6a(Up to 15 months)
- Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29(Up to 15 months)
- Change From Baseline in General Self-Efficacy - Short Form 4a(Up to 15 months)
- Change From Baseline in Global Physical Activity Questionnaire(Up to 15 months)
- Change From Baseline in McGill Pain Questionnaire(Up to 15 months)
- Change in Charlson Comorbidity Index(Up to 15 months)
- Change From Baseline in Financial Strain(Up to 15 months)
研究者
Gwendolyn Sowa
Professor and Chair Department of Physical Medicine and Rehabilitation
University of Pittsburgh